Cleared Special

DATEX-OHMEDA HMEF MINI

K023641 · Datex-Ohmeda · General Hospital
Nov 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K023641 is an FDA 510(k) clearance for the DATEX-OHMEDA HMEF MINI, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on November 27, 2002, 28 days after receiving the submission on October 30, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K023641 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2002
Decision Date November 27, 2002
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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